Transcript C H Helen Betts – Lead Research Nurse PICS-SG Cambridge 2005 C H The CHIP Trial – Developed jointly by PICS-SG clinicians and LSHTM Clinical Trials.

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Helen Betts – Lead Research Nurse
PICS-SG Cambridge 2005
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The CHIP Trial
– Developed jointly by PICS-SG clinicians and
LSHTM Clinical Trials Centre
– Funded by DoH HTA July 2006
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The CHIP Trial
A randomised, controlled trial comparing
‘Tight Glycaemic Control’ with conventional
(‘permissive’) glycaemic control in critically
ill and post-surgical children in Paediatric
Intensive Care
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Organisation
Steering
committee
DMC
DoH
HTA
Trial
Management
group
RBH
Clinical
Coordination
/’Sponsor’
CICU
PICU
CICU
LSHTM
Data
Coordinating
centre
PICU
Children and Parents
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CHiP STUDY SITES
Leeds
Manchester
Liverpool
Sheffield
Cambridge
Birmingham
London
Bristol
(St Mary’s, GOSH, RBH)
Southampton
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Trial Administration
• ‘Run in’ period for each centre
• ‘Sign off’ by Trial Management Group
• Performance of research sites will be
monitored
– (recruitment rate; data quality etc.)
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Recruitment
• Aiming to recruit 1500 children over 2 years
from ~ 12 PICU / CICU’s
• Funding for 11 x 0.5 wte Research Nurses
• Role of RN’s
– Ensure recruitment
– ‘Teach’ TGC protocol to clinical team
– Ensure trial documentation complete
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Lead Nurse Role
Linchpin
• Translate theory from protocol making it user
friendly and safe
• Overseeing training needs and providing tools for
safe recruitment
• Work closely with each study site providing support
throughout the life of the study
Tight page 1
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Other support…
website: www.chip-trial.org.uk
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24 hour CHiP telephone support
Tel : 07854 980072
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Study Sites and Research Teams
Royal Brompton Hospital:
CI / PI - Duncan Macrae
Lead Nurse - Helen Betts
Carolyn Webster
(Sponsor Site)
St Mary’s Hospital, London:
PI - David Inwald
TBA
Emma Waite
Great Ormond Street Hospital:
PI - Mark Peters
(PICU)
PI - Mike Broadhead (CICU)
TBA
London MCRN:
Louise Spencer
Lorraine Hodgson
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Study Sites and Research Teams
Birmingham Children’s Hospital:
PI - Kevin Morris
Simon Laker
MCRN: Pauline Darbyshire
Lisa Hydes
Manchester Children’s Hospital:
PI - Peter-Marc Fortune
Chloe Rishton
MCRN: Mark Sidaway
Sheffield Children’s Hospital:
PI - Anton Mayer
TBA
MCRN: Penny Scardifield
Sam Jones
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Study Sites and Research Teams
Liverpool Alder Hey Children’s Hospital:
PI MCRN:
Paul Baines
Katie Blackie
Helen Hill
Southampton:
PI -
John Pappachan
Helen Cracknell
Lucy Grace
Lorna St John
Leeds:
PI -
Mark Darwski
TBA
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Study Sites and Research Teams
Cambridge:
Bristol Children’s Hospital:
PI - Robert Tasker
Deborah White
PI - Margrid Schindler
TBA
Caroline Haines
MCRN: Natalie Fineman
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Progress to date….
• 9 sites with Ethical approval
• 3 with R & D approval
• RN recruited in 4 sites
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Help…..
• Obtain R&D and LREC approval at remaining sites
• Recruit a Research nurse for remaining sites
• Involve the whole PICU team
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The biggest PICU study ever to be performed in the UK and
an amazing opportunity to work in collaboration with so
many centres of excellence
No evidence of the effect of TGC in children
CHiP will provide an evidence basis for future management
of critically ill children
CHiP Needs